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bayoubengals88
Wisconsin Fan
LA
Member since Sep 2007
12168 posts

AUPH - POSITIVE Phase 3 data; $167.7 Million offering at $15/share
Buyout next??

Aurinia Announces Positive AURORA Phase 3 Trial Results Demonstrating Voclosporin Superiority Over Standard of Care in Lupus Nephritis

DECEMBER 04, 2019
quote:


- Voclosporin achieved statistically superior Renal Response rate (p < 0.001) and comparable safety profile versus standard of care -

- Statistically significant results demonstrated in all pre-specified hierarchical secondary endpoints -

- Aurinia plans to file an NDA submission to the FDA during the first half of 2020 -

- Company to host conference call to discuss results at 8:30 a.m. ET on Thursday, December 5, 2019 -

VICTORIA, British Columbia--(BUSINESS WIRE)-- Aurinia Pharmaceuticals Inc. (NASDAQ: AUPH / TSX:AUP) (“Aurinia” or the “Company”), a late-stage clinical biopharmaceutical company focused on advancing voclosporin across multiple inflammatory and autoimmune conditions, today announced positive efficacy and safety results from its pivotal AURORA Phase 3 trial of voclosporin, in combination with mycophenolate (“MMF”) and low-dose corticosteroids, in the treatment of lupus nephritis (“LN”).

“This extraordinary pivotal data confirms voclosporin’s ability to achieve statistically significant improvements in clinically meaningful endpoints for this complex disease, with a comparable safety profile to the current standard of care,” said Neil Solomons, M.D., Chief Medical Officer of Aurinia. “This data represents a significant advance for people living with LN, which can lead to irreversible kidney damage, eventual kidney failure and death.”

This global study in which 357 patients with active LN were enrolled, met its primary endpoint of Renal Response rates of 40.8% for voclosporin vs. 22.5% for the control (OR 2.65; p < 0.001). Additionally, all pre-specified hierarchical secondary endpoints achieved statistical significance in favor of voclosporin, which included Renal Response at 24 weeks, Partial Renal Response at 24 and 52 weeks, time to achieve urinary protein-to-creatinine ratio (“UPCR”) = 0.5, and time to 50% reduction in UPCR. The robustness of the data was also supported by all pre-specified subgroup analyses (age, sex, race, biopsy class, region, and prior MMF use) favoring voclosporin.




Old updates for posterity:
And this one is not AS binary as many think:

31 October: Aurinia Announces Initiation of Patient Dosing in Phase 2/3 AUDREY™ Clinical Trial for Dry Eye Syndrome

- Voclosporin ophthalmic solution (VOS) AUDREY trial results anticipated in the second half of 2020 –

[quote]VICTORIA, British Columbia--(BUSINESS WIRE)-- Aurinia Pharmaceuticals Inc. (NASDAQ: AUPH / TSX:AUP) (“Aurinia” or the “Company”), a late-stage clinical biopharmaceutical company focused on advancing voclosporin across multiple inflammatory and autoimmune conditions, today announced the initiation of patient dosing in the Phase 2/3 AUDREY™ clinical trial evaluating voclosporin ophthalmic solution (“VOS”) for the potential treatment of dry eye syndrome (“DES”).

“Based upon the impressive results seen with VOS in the head-to-head exploratory Phase 2a study against cyclosporin A, we are focused on rapidly advancing this promising treatment for those who suffer from dry eye syndrome,” commented Peter Greenleaf, President and Chief Executive Officer of Aurinia. “Through the Phase 2/3 AUDREY trial, we will generate important dose-ranging and clinical data aimed at bringing VOS towards registration and commercialization.”

The AUDREY trial is a randomized, double-masked, vehicle-controlled, dose-ranging study evaluating the efficacy and safety of VOS in subjects with DES. A total of approximately 480 subjects are expected to be enrolled. The study will consist of four arms with a 1:1:1:1 randomization schedule, in which patients will receive either 0.2% VOS, 0.1% VOS, 0.05% VOS or vehicle, dosed twice daily for 12 weeks. The primary outcome measure for the trial is the proportion of subjects with a 10mm improvement in Schirmer Tear Test (“STT”) at four weeks. Secondary outcome measures will include STT at other time points, Fluorescein Corneal Staining (“FCS”) at multiple time points, change in eye dryness, burning/stinging, itching, photophobia, eye pain and foreign body sensation at multiple time points, and additional safety endpoints. Top-line results from the AUDREY clinical study are anticipated during the second half of 2020.



This post was edited on 12/10 at 9:01 am


MarkInTable
LSU Fan
Dallas, TX
Member since Aug 2016
99 posts

re: AUPH - POSITIVE Phase 3 data; $167.7 Million offering at $15/share
I'm holding ~300 shares until the big payday.


tipup
LSU Fan
Member since Sep 2005
1649 posts

re: AUPH - POSITIVE Phase 3 data; $167.7 Million offering at $15/share
In 2013 it was $214.00 a share? WTF happened?


MSTiger33
LSU Fan
New York City
Member since Oct 2007
15350 posts
 Online 

re: AUPH - POSITIVE Phase 3 data; $167.7 Million offering at $15/share
Holding big time on this one. I plan to buy more as soon as the garbage management at ADMP gets off its arse and sign Pship or BO papers.

Everything I read says AUPH is the golden goose.


bayoubengals88
Wisconsin Fan
LA
Member since Sep 2007
12168 posts

re: AUPH - POSITIVE Phase 3 data; $167.7 Million offering at $15/share
quote:

In 2013 it was $214.00 a share? WTF happened?


No, it's never been about $10.50
It wasn't listed until the end of 2013


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bayoubengals88
Wisconsin Fan
LA
Member since Sep 2007
12168 posts

re: AUPH - POSITIVE Phase 3 data; $167.7 Million offering at $15/share
quote:

Everything I read says AUPH is the golden goose.
My favorite thing about this company is the CEO and the management under him. These guys have so much experience, and have been successful with buyouts in the past. I mean, hell, Glickman was able to sell a drug with 10% remission rate...Voclosporin (AUPH drug) boasts a 50% remission rate. Five times better than the standard care!

I just watched Cramer's interview with Glickman from a few months ago. According to that we'll have some new indications to discuss come Friday.

But I'm with you. I'll likely keep buying below $7 (less now than when it was $3.40 though)
1,600 shares and counting.


MSTiger33
LSU Fan
New York City
Member since Oct 2007
15350 posts
 Online 

re: AUPH - POSITIVE Phase 3 data; $167.7 Million offering at $15/share
The management is as solid as it comes. Goal is to get at least 10,000 shares. ADMP is screwing up my timeline. I was hoping that ADMP would have popped by now. Want to roll over those gains to AUPH


bayoubengals88
Wisconsin Fan
LA
Member since Sep 2007
12168 posts

re: AUPH - POSITIVE Phase 3 data; $167.7 Million offering at $15/share
I don't know this one. They're hoping for a partnership soon?


MSTiger33
LSU Fan
New York City
Member since Oct 2007
15350 posts
 Online 

re: AUPH - POSITIVE Phase 3 data; $167.7 Million offering at $15/share
Yeah. They have an FDA approved cheaper competitor to the EpiPen. Been sitting on it for months. They also have three generic inhalers about to enter P3. The problem is that this company has the worst management I have ever seen in a company. It is borderline criminal what they are (or should I say are not) doing.


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ynlvr
LSU Fan
Gulf Coast
Member since Feb 2009
2773 posts

re: AUPH - POSITIVE Phase 3 data; $167.7 Million offering at $15/share
Bought in under $4, rode it through $10 and back, bought more at $6.98, holding big bag ‘o AUPH. Holding for a triple from here.


jmcwhrter
Member since Nov 2012
1755 posts

re: AUPH - POSITIVE Phase 3 data; $167.7 Million offering at $15/share
Been watching this one for months.. They really looking at a 2019 timeframe for Phase 3 results?


bayoubengals88
Wisconsin Fan
LA
Member since Sep 2007
12168 posts

re: AUPH - POSITIVE Phase 3 data; $167.7 Million offering at $15/share
Yep. Straight from Glickman's mouth. Long wait, but that's ok.


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cuyahoga tiger
LSU Fan
NE Ohio via Tangipahoa
Member since Nov 2011
4507 posts

re: AUPH - POSITIVE Phase 3 data; $167.7 Million offering at $15/share
I'm averaged at 4.87 after I sold 2/3 of my position at 8ish... buying more today... staying long... I think


bayoubengals88
Wisconsin Fan
LA
Member since Sep 2007
12168 posts

re: AUPH - POSITIVE Phase 3 data; $167.7 Million offering at $15/share
So what do we have so far?

1) New indication is for Dry Eye Syndrome
Aurinia has already partnered with Merck for Canine Dry Eye, but withheld the rights to human.

2) No new capital needed.

3) Market for Lupus Nephritis up to 5.5 Billion (was 2-3 billion). The buyout price just got higher....

This post was edited on 10/20 at 7:46 am


bayoubengals88
Wisconsin Fan
LA
Member since Sep 2007
12168 posts

re: AUPH - POSITIVE Phase 3 data; $167.7 Million offering at $15/share
Phase III is said to be primarily composed of healthy US and Canadian patients, which is great.


GREENHEAD22
LSU Fan
Member since Nov 2009
13501 posts
 Online 

re: AUPH - POSITIVE Phase 3 data; $167.7 Million offering at $15/share
Is anyone seeing a drop in the future, thinking of picking some more up.


bayoubengals88
Wisconsin Fan
LA
Member since Sep 2007
12168 posts

re: AUPH - POSITIVE Phase 3 data; $167.7 Million offering at $15/share
There's no reason for a drop below $6
Today's news was fantastic in every way...it just wasn't news of a buyout.


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MSTiger33
LSU Fan
New York City
Member since Oct 2007
15350 posts
 Online 

re: AUPH - POSITIVE Phase 3 data; $167.7 Million offering at $15/share
quote:

Is anyone seeing a drop in the future, thinking of picking some more up.


Its going to be a rollercoaster. I expect there will be a number of dips that will provide a number of buying opportunities.


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Ray Finkle
LSU Fan
Collier county
Member since Sep 2007
1171 posts

re: AUPH - POSITIVE Phase 3 data; $167.7 Million offering at $15/share
Taking a pounding today. Yikes


chadau79
Auburn Fan
Daphne, AL
Member since Sep 2009
3209 posts

re: AUPH - POSITIVE Phase 3 data; $167.7 Million offering at $15/share
Big time.


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